Your session is about to expire
← Back to Search
Cladribine After Natalizumab for Multiple Sclerosis
Study Summary
This trial will assess the safety and efficacy of the drug cladribine after treatment with natalizumab in patients with RRMS and active SPMS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 3 trial • 867 Patients • NCT00641537Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am positive for HIV or hepatitis B/C.I have been diagnosed with or suspected to have PML.I have been treated with cladribine before.I have been diagnosed with Clinically Isolated Syndrome.I am not pregnant or breastfeeding.My MS is not getting worse.You are allergic to cladribine.I have been diagnosed with a relapsing form of MS.My doctor thinks Natalizumab didn't work for me.Your blood platelet or white blood cell counts are too low.I have not taken steroids by mouth or injection in the last 28 days.I have been on natalizumab (300 mg daily) for at least 12 months.I understand and can follow the study's requirements.I am using effective birth control and will continue for 6 months after my last dose.I have not received a live vaccine in the last 6 weeks and do not plan to during the trial.I am immunocompromised or currently on therapy that weakens my immune system.You are allergic to gadolinium or have any reason that prevents you from getting an MRI.I haven't had any relapses in the last 28 days.I have not had cytokine, IVIG, or plasmapheresis treatments in the last 3 months.I have had tuberculosis or currently have it.Your lymphocyte count is not in the normal range according to the local hospital's lab tests.I have been treated with drugs that lower my blood cell counts.I will use a condom for six months after my last dose, or my partner will use contraception.I weigh at least 40 kilograms.I cannot receive gadolinium due to a kidney condition.I have or had cancer.I am between 18 and 60 years old.I can walk without aid or rest for at least 200 meters.
- Group 1: Cladribine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Under what circumstances would this medicinal intervention be prescribed?
"This therapeutic intervention is utilized to address ctage1 protein in human patients. Furthermore, it can be effective at treating hairy cell leukemia, multiple sclerosis, and certain imaging diagnostics."
What evidence is there to support the safety of this treatment for patients?
"This treatment has been verified, so it is assigned a score of 3 on our safety scale at Power. This rating reflects the fact that this drug is already approved and in Phase 4 trials."
What is the enrollment capacity for this medical experiment?
"Unfortunately, this clinical trial is not accepting participants at the moment. It was first listed on February 19th 2020 and updated most recently on September 30th 2022. If you are interested in participating in a medical study for MS, there are currently 390 others recruiting with 34 trials specifically pertaining to this treatment."
Are there precedents of research done on this particular therapeutic approach?
"Currently, the treatment is being investigated in 34 active studies with 7 trials at Phase 3. Houston, Texas serves as a main hub for these investigations and 359 medical sites are participating in relevant clinical experiments."
Is there an age restriction for enrollment in this trial?
"Eligibility for this medical experiment is restricted to individuals between the ages of 18 and 60. Patients under 18 are able to enroll in 29 different clinical trials, while those over 65 may join 270 such initiatives."
Is it possible to partake in this medical experiment?
"This medical trial seeks 40 volunteers that have been diagnosed with Multiple sclerosis and are aged 18 to 60. Male participants must use a condom throughout the study duration, while female enrollees need an additional form of contraception like an intra-uterine device or hormonal options such as implants, injectables, patches or oral contraceptives for the same amount of time. Other requirements include having EDSS between 0 and 5.5; 12 months continuous natalizumab therapy (300 mg/d); no relapses in last 28 days; weighing at least 40 kilograms; not being pregnant nor lactating 10 days after completion of treatment; and understanding"
Is the enrollment process still open for this investigation?
"Unfortunately, the recruitment window for this trial has closed and it was last edited on September 30th 2022. Nevertheless, there are other opportunities available as 390 clinical trials with relevance to multiple sclerosis currently require participants and 34 studies related to this treatment also need volunteers."
Share this study with friends
Copy Link
Messenger